QA Document Control Specialist
Legend Biotech · BE
Want to Make a Real Impact? Join Our QA Document Control Specialist Talent Pool!
Job description
Want to Make a Real Impact? Join Our QA Document Control Specialist Talent Pool! The Quality Assurance Document Control Specialist role is a position with responsibilities for supporting the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system, document storage and retention, and document issuance and reconciliation. What can you expect?: - Responsible for managing the document control systems and processes for the site. - Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with global and site procedures. - Support Document Management system users with workflow handling and electronic system usage. - Manage the periodic review process for procedures. - Issuance of batch related documentation in support of GMP manufacturing. - Reconcile GMP documentation following document lifecycle requirements. - Creation and issuance of GMP logbooks. - Responsible for storage and archival of GMP documents and batch related records. - Perform tasks in a manner consistent with...